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Could be participant in study with goal of walking

This isn't really about a total cure for SCI, but I thought it would fit here.

Last week my husband was offered to be one of five local participants in a research study. We were urged to take our time in deciding, as it is a pretty hefty time commitment and there is surgery involved, etc.

Introduction and Background Information
You are invited to take part in this research study because the results of the screening process have shown that you are eligible for participation. This study involves a non-indicated use of a FDA approved device and the manufacturer has not completed testing with the device as it will be used in this study. The study is being conducted by Dr. Susan Harkema, Dr. Jonathan Hodes and Dr. Douglas Stevens. The study is sponsored by the National Institutes of Health and the University of Louisville, Department of Neurological Surgery and will take place at University Hospital and the Frazier Rehab Institute in Louisville. Approximately 5 local individuals with spinal cord injury will be invited to participate in this study. Your participation in this study will last for approximately 3 years. After 3 years a decision will be made as to whether the spinal stimulator will be left in place or removed. If the stimulator is beneficial, it will be left in place. If ineffective, a decision will be made to keep the stimulator in place or remove it. Long term follow-up after 3 years will consist of visits to the clinic every 6 months at no cost to you until the device is removed or the device is approved by the FDA.

Purpose
The purpose of this research study is to investigate the combined effects of stand and step (locomotor) training with electrical stimulation of the spinal cord in patients who have had a complete spinal cord injury. We hope to show that this treatment will increase the muscle strength in your extremities. It is known that patients with severe spinal cord injury are able to be trained using locomotor training. Locomotor training is a process to develop activity in the nerves and muscles of patients with a spinal cord injury during standing and stepping with assistance from people. As well, electrical stimulation of the spinal cord following spinal cord injury in animals demonstrates a walking-like motion. The information learned in this study will be used to find the best conditions to assist patients to stand and walk using electrical spinal cord stimulation and locomotor training.

Surgery
A 4 to 6 inch cut will be made in your lower back and one or two electrodes (devices to produce electrical stimulation) measuring approximately ½ x 3” will be inserted in your spinal canal.
During this 4-5 hour operation several electrical stimulations will be given to your spinal cord in order to determine the best place for the sensor.
One or two 3” x 1/2” battery (generators) will be put under your skin through a cut placed in the lower abdomen (one on each side). The subject and investigator will be able to adjust the electrical stimulator by external device.

Locomotor Training
The locomotor training program will take place approximately two weeks after your surgery.
Each locomotor step training sessin will last about 1-2 hours and will occur up to 5 times weekly for a total of 80 sessions.
You will be helped to step on a treadmill while wearing a harness that is attached to an overhead suspension device that will support the weight of your body. There will be one person behind you and at your hips to help keep you stable. There will also be one person at each of yoru legs to assist you by helping you to put weight on your legs and to swing your legs.
If you feel tired or need a break during the session you can take a break at any time.
In the 80 sessions, the goal will be to reach your maximum comfortable walking speed on the treadmill with no assistance from the overhead suspension device that will support the weight of your body.

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So far, one other person has been implanted with the device and we were told we would be able to talk with him before making our decision. I would like to hear opinions and suggestions of questions to ask the other participant and/or the doctors. So far our questions are:

*What about the 3 part treatment done with rats? Will medication be used with this study or with different subjects - why or why not?
From what I've read, if I'm understanding correctly:
Rats w/e-stim & locomotor regained walking-like motion.
Rats w/e-stim, locomotor & medication regained walking.

Thanks Linda. We're doing "okay" - you know how it goes Ups and downs, busy with "regular life" with the kids and everything, therapy and appointments, court, etc. I'm really hoping Ryan can do this study, but we have to get more info on it.

the whole "implanting a device" thing would be a concern for me.......and 1-2 hrs a day on treadmill w/ someone moving your legs.....u better be sure to get a bone density test before to ensure stability......

the whole "implanting a device" thing would be a concern for me.......and 1-2 hrs a day on treadmill w/ someone moving your legs.....u better be sure to get a bone density test before to ensure stability......

Yeah, the implanting a device and the surgery itself is concern. He already does the treadmill like this at rehab (a harness holds up a lot of his weight). He has had a bone density test done. Hopefully soon we'll be able to talk with the person who has been implanted.